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An experienced medical writing consultancy
Scinopsis is an experienced medical writing consultancy providing high quality documents for the pharmaceutical, biotechnology and medical device industries.
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CLINICAL TRIALS DOCUMENTATION
- Protocols and informed consent forms
- Clinical study reports
- Patient narratives
- Investigator brochures
- Investigational medicinal product dossiers (IMPD)
- Registry postings
- Lay summaries
REGULATORY DOCUMENTS
- Briefing packages
- NDA/MAA/CTD clinical modules
- Responses to EMA/FDA questions
- Integrated summaries of safety & efficacy
- PIP/PSP & waivers
- Risk management plans
- Orphan designation applications
- Core value dossiers
MEDICAL COMMUNICATIONS
- Publications
- Literature reviews
- Systematic reviews
- Slides, posters & abstracts
- Conference reports
- Medical education materials
MEDICAL DEVICES
- Clinical investigation plans
- Clinical investigation reports
- Clinical evaluation reports
- Medical device publications
OUR EXPERTS
- Highly qualified scientists (PhD or MD)
- Native English (or equivalent)
- International team located in France and the UK
- Expertise in a wide range of document types and therapeutic areas
- Expert writing and communication skills
QUALITY IS OUR TOP PRIORITY
- Robust quality management system
- Successful client audits
- Full compliance with EMA, FDA and ICH guidelines
- In-house document review and quality control
- Excellent reputation in the industry
- Preferred-provider for several customers
- Many highly satisfied customers